AAY ESS STEELS
⚠️ Moderate Risk
FEI: 3004818801 • Ludhiana, Punjab • INDIA
FEI Number
3004818801
Location
Ludhiana, Punjab
Country
INDIAAddress
639, , Ludhiana, Punjab, India
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/23/2005 | 76LCNSCRAPER, TONGUE | 341REGISTERED | Baltimore District Office (BLT-DO) |
| 3/23/2005 | 76EFWTOOTHBRUSH, MANUAL | 341REGISTERED | Baltimore District Office (BLT-DO) |
| 3/23/2005 | 76EFWTOOTHBRUSH, MANUAL | 341REGISTERED | Baltimore District Office (BLT-DO) |
| 3/23/2005 | 65CBL99NUTRIENT/TONIC N.E.C. | 118NOT LISTED | Baltimore District Office (BLT-DO) |
| 3/23/2005 | 65CBL99NUTRIENT/TONIC N.E.C. | 118NOT LISTED | Baltimore District Office (BLT-DO) |
Frequently Asked Questions
What is AAY ESS STEELS's FDA import refusal history?
AAY ESS STEELS (FEI: 3004818801) has 5 FDA import refusal record(s) in our database, spanning from 3/23/2005 to 3/23/2005.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. AAY ESS STEELS's FEI number is 3004818801.
What types of violations has AAY ESS STEELS received?
AAY ESS STEELS has been cited for 2 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about AAY ESS STEELS come from?
All FDA import refusal data for AAY ESS STEELS is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.